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Description
In China, the number of infertile couples is increasing. According to Chinese media, in 2018, more than 40 million people in China were infertile, with the incidence of infertility in couples of childbearing age increasing from 3% 20 years ago to 15% in recent years. According to the Global Burden of Disease, in 2017, the incidence of infertility was 2,705.66/100,000 in Chinese women and 879.32/100,000 in Chinese men. The common causes of female infertility include ovulation disorders, fallopian tube damages and endometriosis; the major causes of male infertility include varicoceles, infections, ejaculation disorders and anti-sperm antibodies.
The increasing incidence of infertility in China is attributable to the endocrine disorders caused by worsening environmental pollution, increasing life pressures and unhealthy lifestyle, the increase in the average childbearing age of women, and the damages to female fertility caused by induced abortion.
Infertility is mainly treated by drug, surgery and assisted reproductive technology (ART). The drugs are ovulation stimulants that apply to the couples who have no organic disorders. Surgeries apply to organic disorders such as varicoceles in men and blocked fallopian tubes and intrauterine adhesion in women.
If drugs or surgeries do not work or if couples have other indications, ART will be applied. About 20% infertility patients are treated by ART. ART procedures mainly include artificial insemination (AI) and in vitro fertilization and embryo transfer (IVF-ET, or test-tube baby) and their derivative technologies. They bring higher pregnancy rate than drugs and surgeries. As the success rate of AI is lower, some patients directly choose IVF-ET. And some patients turn to IVF-ET after repeated AI failures. At the end of 2018, more than 450 medical institutions were qualified to implement ART, of which 350 could implement IVF-ET and more than 40 could provide pre-implantation genetic diagnosis; the number of ART practitioners reached 10,000; the clinical pregnancy rate of ART in China was 40% and the live birth rate was 30% to 35%. China have over 200,000 newborn test-tube babies every year, ranking the first in the world.
In 2006, the Recombinant Follitropin Beta injection by Merck Sharp & Dohme became the first Recombinant Follitropin Beta product approved to be sold in China. In 2011, Recombinant Follitropin Beta (trade name: Puregon) by Organon (now affiliated to Merck Sharp & Dohme) was approved to be sold in China. And all the Recombinant Follitropin Beta products on the Chinese market are the products of Organon. The sales value of Recombinant Follitropin Beta kept rising after the drug entered China. It reached about CNY 126 million in 2017.
In China, Recombinant Follitropin Beta is used to treat anovulation (including polycystic ovary disease, PCOD) that cannot be cured by clomiphene citrate. It is also used in ART procedures such as IVF-ET, gamete intrafallopian transfer (GIFT) and Intracytoplasmic sperm injection (ICSI) for controlled ovarian hyperstimulation and follicular development.
As the incidence of infertility increases, the demand for Recombinant Follitropin Beta in China will keep growing. From 2019 to 2023, China’s Recombinant Follitropin Beta market will continue to expand. In the next few years, Recombinant Follitropin Beta products by enterprises other than Organon will possibly be launched in China.

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